The Role of Intestinal Ultrasound in Monitoring the Response to Biological Therapy in Patients With Ulcerative Colitis

NCT05606939 | Unknown

• 1 other identifier: IUS in ulcerative colitis
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, the investigators aim to evaluate the role of intestinal ultrasound in evaluation of the therapeutic response to biological therapy in patient with ulcerative colitis

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• the role of intestinal ultrasound in evaluation of the therapeutic response to biological therapy in patient with ulcerative colitis

  All patients will be evaluated using intestinal ultrasound with special emphasis on intestinal wall thickness in mm as well as stratification normal or dirupted and Visualization of the vascularization (normal decrease or increased) of the bowel using color Doppler sonography also visualization of motility (normal , increased or decreaed) Findings of intestinal ultrasound will be compared regrading colonoscopic findings to evaluate the response to biological therapy through IUS

  Baseline , 2 weeks , 6 weeks

Interventions

intestinal ultrasound DEVICE

All patients will be evaluated using intestinal ultrasound with special emphasis on intestinal wall thickness as well as stratification and Visualization of the vascularization of the bowel using color Doppler sonography also visualization of motility. Findings of intestinal ultrasound will be compared regrading colonoscopic findings

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient above age of 18 years old and diagnosed to have UC and whom not responding to conventional medical therapy and eligible for biological therapy will be recruited in this study

You may qualify if:

• Any patient above age of 18 years old and diagnosed to have UC and whom not responding to conventional medical therapy and eligible for biological therapy will be recruited in this study
• moderate to severe UC patients
• immunosuppressant or corticosteroid refractory disease
• those with intolerance or contraindication to conventional therapies are eligible to be treated with biological therapy

You may not qualify if:

• Patients with UC who are under age of 18 years' old
• Patients with UC who aren't eligible to biological therapy
• patients with complication of UC(fistula , intestinal obstruction , intestinal perforation ,……)
• Patient refuse to participate in the study.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Zakeri N, Pollok RC. Diagnostic imaging and radiation exposure in inflammatory bowel disease. World J Gastroenterol. 2016 Feb 21;22(7):2165-78. doi: 10.3748/wjg.v22.i7.2165.

  PMID: 26900282 BACKGROUND

• Atkinson NSS, Bryant RV, Dong Y, Maaser C, Kucharzik T, Maconi G, Asthana AK, Blaivas M, Goudie A, Gilja OH, Nuernberg D, Schreiber-Dietrich D, Dietrich CF. How to perform gastrointestinal ultrasound: Anatomy and normal findings. World J Gastroenterol. 2017 Oct 14;23(38):6931-6941. doi: 10.3748/wjg.v23.i38.6931.

  PMID: 29097866 BACKGROUND

• Jauregui-Amezaga A, Rimola J. Role of Intestinal Ultrasound in the Management of Patients with Inflammatory Bowel Disease. Life (Basel). 2021 Jun 23;11(7):603. doi: 10.3390/life11070603.

  PMID: 34201630 BACKGROUND

• Novak KL, Nylund K, Maaser C, Petersen F, Kucharzik T, Lu C, Allocca M, Maconi G, de Voogd F, Christensen B, Vaughan R, Palmela C, Carter D, Wilkens R. Expert Consensus on Optimal Acquisition and Development of the International Bowel Ultrasound Segmental Activity Score [IBUS-SAS]: A Reliability and Inter-rater Variability Study on Intestinal Ultrasonography in Crohn's Disease. J Crohns Colitis. 2021 Apr 6;15(4):609-616. doi: 10.1093/ecco-jcc/jjaa216.

  PMID: 33098642 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Abanoub Melk

CONTACT

01228261560; abanoub.ayoub@med.aun.edu.eg

Magda Hasan, MD

CONTACT

01066900939; Magda_sh@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at tropical medicine and gastroenterology

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: November 7, 2022
• Study Start: January 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: March 12, 2024
• Last Updated: November 7, 2022

Record last verified: 2022-10